H.R. 4191 — MAPS Act

This section directs the Secretary of Health and Human Services, in coordination with other relevant federal agencies and consultation with stakeholders, to update and maintain the Essential Medicines List—initially developed pursuant to Executive Order 13944—to include active pharmaceutical ingredients and drugs (1) directly related to responding to chemical, biological, radiological, or nuclear threats under the National Response Framework; (2) of greatest priority for health care and at high risk of shortage; or (3) whose shortage would pose adverse health outcomes for patients with chronic conditions. The Secretary must review the list at least every two years and update it as necessary, complete the initial update within 180 days of enactment, and publish the list promptly after each update.

This section directs the Secretary of Health and Human Services, in consultation with relevant federal departments and agencies, to conduct a comprehensive risk assessment of supply chains for active pharmaceutical ingredients and drugs on the Essential Medicines List. At a minimum, the assessment must identify (1) key starting materials and excipients; (2) items relying on foreign suppliers for more than 50% of production; (3) items sourced exclusively or primarily from a single supplier; (4) current domestic manufacturing capabilities, including for key materials and advanced technologies; (5) public health and national security risks, including cybersecurity threats; (6) federal deficiencies or limitations in addressing such risks; and (7) federal mitigation strategies, including under the Defense Production Act of 1950. The Secretary must submit a report on the assessment to relevant congressional committees within 180 days of enactment and annually thereafter.

This section directs the Secretary of Health and Human Services (HHS), in coordination with other relevant federal agencies, to map supply chains—from manufacturing of key starting materials through finished dosage forms and distribution—of drugs (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act) included on the Essential Medicines List under section 2 of this Act; and to use data analytics to identify vulnerabilities threatening public health or national security. In doing so, the Secretary must (1) describe roles and responsibilities of HHS agencies and offices in monitoring such supply chains and assessing vulnerabilities, and (2) facilitate information exchange among federal entities, including production locations and amounts for active pharmaceutical ingredients, finished dosage forms, key starting materials, and excipients at registered establishments, as well as regulatory actions such as inspections, seizures, recalls, drug shortages, and production interruptions. Not later than 18 months after enactment, and annually thereafter, the Secretary must report to relevant congressional committees on the status of mapping and analysis efforts, coordination activities, identified roles and gaps, use of predictive modeling for shortages or risks, and industry engagement.

This section defines, for purposes of the Act, (1) "advanced manufacturing" as having the meaning given "advanced and continuous pharmaceutical manufacturing" in the 21st Century Cures Act; (2) "cybersecurity threat" as defined in the Homeland Security Act of 2002; (3) "drug" as defined in §201(g) of the Federal Food, Drug, and Cosmetic Act; and (4) "Secretary," except as otherwise specified, as the Secretary of Health and Human Services.

This section provides additional implementation provisions, including (1) deeming the Secretary's participation in developing and updating the list of essential medicines under section 2 to fully satisfy requirements applicable to the Secretary under section 3 of Executive Order 13944 (85 Fed. Reg. 49929); (2) specifying that information exchanges among the Secretary and heads of relevant federal departments and agencies to carry out sections 3 and 4 do not violate 18 U.S.C. 1905 (i.e., prohibition on unauthorized disclosure of trade secrets and confidential commercial information by federal officers and employees), without affecting such information's status under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), the Freedom of Information Act (5 U.S.C. 552), or 18 U.S.C. 1905; and (3) directing the Secretary to ensure robust cybersecurity measures to prevent inappropriate access to or unauthorized disclosure of information identified, exchanged, or disclosed under sections 3 and 4.